This is to inform the concerned stakeholders of the compliance to Administrative Order (AO) 2013-0027, or the rules on “Adoption and Implementation of World Health Organization (WHO) Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products, and Annex 9 Guide to Good Storage Practices (GSP) for Pharmaceuticals” which directs all drug establishments and retailers to adopt the current version of WHO GDP and GSP guide as the standard for good storage and distribution practices for medical products.
The AO likewise expressly declares that all supplements and revisions related to the WHO Annex 5 – Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 – Guide to Good Storage Practices for Pharmaceuticals shall be adopted automatically.
In 2020, the WHO had published an update of the good storage and distribution practices guideline which sets out the steps required by different stakeholders in the supply chain to fulfill their responsibilities in avoiding the introduction of substandard and falsified products into the market. In particular, it offers guidelines for storing and distributing medical products; it is intended to supplement, rather than replace, national or regional guidelines to meet specific needs or contexts.
The gap assessment conducted showed that there were no relevant changes on the recently issued guidelines on Good Storage and Distribution Practices. In general, this new issuance merged the previous TRS 957, 2010 Annex 5 (GDP) with TRS 908, 2003 Annex 9 (GSP).
This advisory is being issued to provide guidance on the strict compliance of the Administrative Order. The updated guideline can be accessed at the FDA official website through this link: https://www.fda.gov.ph/who-trs-1025-annex-7-good-storage-and-distribution-practices-for-medical-products/
Dissemination of this advisory to all concerned is hereby requested.